Application 071011

Type: ANDA
Sponsor: ACINO PRODS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACETAMINOPHEN	ACETAMINOPHEN	SUPPOSITORY;RECTAL	650MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A071011-001	ACETAMINOPHEN	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL			1987-05-12

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071011-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1987-05-12	`f41ea6bd6efb…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 7 of 51 · 1,003 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen Regular Strength	ACETAMINOPHEN	Aurohealth LLC	dce938f5-eeba-4a76-9261-2b1324c39a31	2026-06-08	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Mapap	ACETAMINOPHEN	Bryant Ranch Prepack	69c90cc8-846a-42cf-933a-108671689e8f	2026-06-05	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	ASCLEMED USA INC.	707a9ea7-8f4e-4274-97bd-b8071a0ee06b	2026-06-04	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
Medline	ACETAMINOPHEN	Medline Industries, LP	fc5e6f2a-e813-0666-e053-6394a90a66a7	2026-06-04	Warnings	Name fallback generic name: ACETAMINOPHEN
Medline	ACETAMINOPHEN	Medline Industries, LP	fc5d92c2-4bbe-8ad1-e053-6294a90a65b6	2026-06-04	Warnings	Name fallback generic name: ACETAMINOPHEN
acetaminophen	ACETAMINOPHEN	Unit Dose Solutions, Inc.	537219ac-552a-a30e-e063-6394a90aa9d1	2026-06-04	Warnings	Name fallback brand name: acetaminophen generic name: ACETAMINOPHEN
Pain Relief childrens	ACETAMINOPHEN	CVS PHARMACY	ff878f56-125a-4de7-b063-029f7030733d	2026-06-04	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Mapap	ACETAMINOPHEN	Major Pharmaceuticals	efec6af2-8b26-47f6-88c8-b0a6d69a2d7d	2026-06-03	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	COSTCO WHOLESALE CORPORATION	3745aa18-a711-43ed-9bc4-1f087b3c53c0	2026-06-03	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
TYLENOL Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	3f653262-b931-7d42-e063-6394a90adddd	2026-06-03	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Reliever	ACETAMINOPHEN	Walgreen Company	0b1bef50-7957-4ea1-9ae3-91f59ea2dbb4	2026-06-03	Warnings	Name fallback generic name: ACETAMINOPHEN
GOOD NEIGHBOR PHARMACY MENSTRUAL PAIN RELIEF	ACETAMINOPHEN	Amerisource Bergen	ae07a064-fdbd-4bb4-8252-9c122bf3dd81	2026-06-02	Warnings	Name fallback generic name: ACETAMINOPHEN
PAIN RELIEF	ACETAMINOPHEN	Meijer, Inc.	1319bab8-8f17-44fb-9d91-099b0ba38a8d	2026-06-01	Warnings	Name fallback generic name: ACETAMINOPHEN
Extra Strength Acetaminophen	ACETAMINOPHEN	TIME CAP LABORATORIES, INC.	58840cf4-aceb-c7cf-e063-6294a90a5ff4	2026-06-01	Warnings	Name fallback generic name: ACETAMINOPHEN
Good Sense Pain Relief	ACETAMINOPHEN	L. Perrigo Company	cb5f6008-6884-402a-8a19-c8d585576d63	2026-06-01	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Pain and Fever	ACETAMINOPHEN	CVS Pharmacy	832acd72-1dda-4490-978f-5f31748942df	2026-06-01	Warnings	Name fallback generic name: ACETAMINOPHEN
Chewable Acetaminophen Childrens	ACETAMINOPHEN	Cardinal Health 110, LLC. DBA Leader	5460a4b7-5da3-4fc2-a565-0b0dd11bbf44	2026-05-29	Warnings	Name fallback generic name: ACETAMINOPHEN
Extra Strength Mini Softgels Pain Reliever	ACETAMINOPHEN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	f55d3663-7007-41cd-ae2d-5aca6311be81	2026-05-28	Warnings	Name fallback generic name: ACETAMINOPHEN
Genexa Kids Pain and Fever	ACETAMINOPHEN	Genexa Inc.	5130c695-a80e-2dd3-e063-6294a90a404f	2026-05-28	Warnings	Name fallback generic name: ACETAMINOPHEN
TYLENOL Regular Strength	ACETAMINOPHEN	Kenvue Brands LLC	1622f694-4d63-4c56-8737-fae31f0ecfb7	2026-05-27	Warnings	Name fallback generic name: ACETAMINOPHEN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.